Advancing Botanical Drug Development Act Seeks to Spur Investment in Plant-Based Medicines

WASHINGTON — A new bipartisan bill introduced in the U.S. House of Representatives aims to stimulate private investment in plant-based medicines by offering a 12-year market exclusivity period for newly approved botanical drugs.

Introduced on Aug. 27 by Rep. Lauren Boebert, R-Colo., and Rep. Derrick Van Orden, R-Wis., the Advancing Botanical Drug Development Act of 2026, or H.R. 10150, seeks to amend the Federal Food, Drug, and Cosmetic Act.

Under the proposed legislation, the FDA would be prohibited from approving generic or hybrid applications that reference a newly approved botanical drug during its 12-year exclusivity window. Supporters of the bill argue this extended period is necessary to overcome the unique scientific, manufacturing, and regulatory challenges that currently discourage private investment under standard intellectual property laws.

Joel Stanley, CEO of AJNA Biosciences noted in an interview with Psychedelic State(s) of America that while the FDA created a regulatory pathway for botanical drugs in 2004, patient demand for evidence-based natural treatments remains unmet due to a stagnation in approvals.

"Before biologics really got their deep funding and became a major category, it was so hard to raise money for them," said Stanley. "When they were given an extended indication exclusivity, that brought money to the space and now there's some good drugs there. ... the purpose is to turn up the heat and get resources to develop these more natural options that could be very important."

Stanley is also the Co-Founder and former CEO of Charlotte’s Web, who alongside his brothers famously created the company’s eponymous, then-first-of-its-kind High CBD, Low THC Cannabis strain credited with revolutionizing epilepsy treatments. Stanley’s new venture AJNA Biosciences is currently developing a novel cannabinoid treatment for Autism Spectrum Disorder, along with a full spectrum psilocybin compound that is entering phase I clinical trials. 

Involvement in the bill’s development was not confined solely to the pharmaceutical sector, either. In an exclusive statement provided to Psychedelic State(s) of America via email, Robert Houton, founder of Mobilizing Accountability in Congress, highlighted his role in spearheading the legislative push 

“I have been a patient advocate [for] ten years [on Capitol Hill]," Houton said, pointing to his previous work mitigating fentanyl poisonings and expanding epinephrine access. "[I helped] initiate the successful effort, leadership, and work in Congress to have the H.R. 10150 legislation introduced, [and] continue to work with Congressional leaders to introduce a companion bill in the U.S. Senate".

The botanical-derived focus of the new legislation comes at a prescient time, given multiple patented synthetic psychedelic compounds are well-positioned for approval by the U.S. Food and Drug Administration (FDA). As first reported by Psychedelic Alpha, last month news broke that Resilient Pharmaceuticals (formerly known as Lykos Therapeutics) had officially resubmitted a previously-rejected New Drug Application for the company’s MDMA-Assisted Therapy treatment, complete with updated safety and clinical trial data. 

More recently, on September 8, 2026, Definium Therapeutics’ patented LSD compound was granted a coveted breakthrough therapy designation by the FDA. The company – formerly known as MindMed – was also awarded a priority review voucher for their LSD compound following the release of “promising” Phase III clinical trial data evaluating the drug for treating General Anxiety Disorder. 

H.R. 10150 emphasizes a shift away from standard single-molecule pharmaceuticals, noting that botanical drugs can contain multiple naturally occurring active constituents capable of safely acting on several biological pathways simultaneously. Recent advances in computational biology and artificial intelligence are cited in the bill as modern tools capable of identifying these multi-pathway botanical formulations.

"We started Western medicine right at the same time that we started being able to synthesize and isolate molecules," said said Stanley. "But with as many great advancements as we've made, we completely left behind the fact that we come from nature, we evolved alongside the natural pairings of molecules found in nature."

Stanley added that standardizing these historical medicines will ultimately bring greater and safer tools to physicians, noting that recent data "marked the first time that we saw in modern days a plant extract surpass the efficacy of multiple FDA-approved drugs."

The push for updated regulatory frameworks extends into the realm of complex botanical and fungal formulations, including ongoing discussions surrounding psychedelic therapies. While praising recent FDA industry guidance for providing regulatory clarity, advocates are pressing for distinct frameworks for sub-perceptual microdosing.

"We need to also look at the sub-perceptual dosing and recognize that it doesn't have a placebo problem at all," Stanley concluded. "It needs to be based on its own data for chronic dosing and not lumped into some of the issues and hurdles that assisted therapy acute high level dosing has."

While the bill was referred to the House Committee on Energy and Commerce on August 27th, as of publication a hearing has not been scheduled.